Prolift Transvaginal Mesh – “A Stupid Idea”

While the defense, Johnson & Johnson, and its Ethicon division, stands by its product, saying it’s helped countless women with prolapse and incontinence, the plaintiffs’ attorney compared it to a plastic octopus and called it “a stupid idea.”

The case promises to be similar to the last Ethicon Prolift transvaginal mesh case, heard more than four years ago in New Jersey, the case of South Dakota nurse, Linda Gross.

Hrymoc’s attorney, Adam Slater (Mazie Slater), also represented Gross and will call many of the same experts.

During the opening Monday, he held the moving piece of polypropylene, with its six arms flailing around, describing it to the jurors as a “defective design that is unreasonably dangerous.”

Adam Slater in Gross trial 2013, Courtesy CVN

The case is Elizabeth Hrymoc v Ethicon, Case No. L-13696-14, heard in New Jersey Superior Court, Bergen Co. NJ, moved from the original New Jersey venue of Atlantic City.

Hrymoc, 71, a research technician from South River in Middlesex County, sat with her husband, Tad, listening to Slater’s opening. They are seeking damages in what NorthJersey.com calls the “largest tort claims litigation in history.”

The website has a video segment of Slater’s opening from Monday, November 27, here.

Tad and Elizabth Hrymoc, from NorthJersey.com

Hrymoc was 62-years-old when she had the two implants – the TVT-O for incontinence the the Prolift, a larger piece of mesh used to shore up sagging pelvic organs.

Slater told jurors that Prolift was sold beginning in March 2005 and withdrawn from the market by J&J, quietly without an official recall, on August 31, 2012.

Four years later, the FDA would reclassify the Prolift and other larger pelvic organ prolapse (POP) meshes as “High risk” or class III, raising the bar on clearance and requiring clinical trials to assure safety and efficacy.

Manufacturers were given 30 months to prove their POP meshes were safe or phase them off the market.

Slater told jurors that polypropylene (PP) mesh could potentially injure the body when implanted and Ethicon knew PP, mixing with bodily fluids, could cause the mesh to stiffen and become brittle. Doctors, even experts agree, it’s almost impossible to completely remove.

PP poses more risk in vaginal tissue and Ethicon knew that but withheld the information from doctors and their patients said Slater.

“This is too much mesh and you will see it in document after document, they knew it was too much mesh… they were looking for lighter weight, larger pore. They had to figure out a way to solve this.”

Prolift, MedTech Marketing

Defense will say that polypropylene mesh was used safely for 60 years but consider the fact that historically that mesh was made into a suture. Transvaginal mesh implants involve a larger quantity of mesh. “The risk/benefit ratio is completely different for a suture than for mesh,” he said.

Jurors must decide based on “the preponderance of evidence.”

Evidence for the plaintiff will show an Ethicon power point plan to bring doctors in and teach them how to use Prolift. Sales reps were told to bring in doctors for training who can do a lot of surgery and influence other doctors, “because this is about money,” he said.

Explaining that some women experience a foreign body reaction to the PP mesh implant, he added that too much material creates a foreign body reaction and “the body rejects the invader.”

“They knew it was too much mesh.”

J&J is a company worth $70 billion and it should pay for its mistakes. “We know the only language they speak is money….. the only way to deter them and to punish them is to make them pay.”

Attorney for Ethicon, Judy Wahrenberger, said Hrymock had a long history of pelvic problems and that all surgeries carry risks. She claimed that Hrymoc’s complications resulted from surgery, not the meshes.

Scott Ciarrocca was called as the first witness. He was an Ethicon engineer who helped bring Prolift to market. Ciarrocca has a background in electrical engineering and still works for Ethicon.

During testimony in the Hammons trial (here), Ciarrocca told jurors that safety concerns over Prolift had been answered and the conclusion was it was safe and effective, despite the 20.1 % failure rate.

I am confused as to why some women are going to trial and the rest of us are waiting on settlements. I was under the understanding that the judge ordered the cases to be consuladated and settlements would be decided based on previous trial outcomes.

I am sick over all of this. It seems like the fight should be over by now. I had a TVT-O and have been told by both Dr. Raz and after an 8 hour surgery by Dr. Hibner that there was no mesh left, 100% removed. I had a translabial ultrasound in the spring that said I have 4″ arm on my right side left. It is impossible to get out. Not almost impossible. I’ve had fragments work their way out too.

Disgusted I am glad u had good Dr’s. I truly believe that our entire pelvis would be mush if they got every bit out. A few years ago I had tiny blue filaments coming out…usually after shower. That was the mesh eroding thru Chk. Did u have trans labial with Hibner?

No, at that time he didn’t do translabial ultrasounds. I don’t know if he does now. He was positive I had mesh left, but he couldn’t find it. So he assumed Dr. Raz did get it. Definitely NOT an exact science.

I want to know about the pain I read about that a lot of women are having. I too have pain. I started having pelvic pain after my first surgery back in 2009. Of course the Doctor said it was my age and to start using Estrace. So I used it, and it did not work, so I suffered in pain. After my 2nd surgery in 2014 I continued to have pain and once again he said to use Estrace and once again it did no good. And then after my 3rd surgery in 2016 I still have pain, so again we tried the Estrace and still no luck. I don’t understand, I never had this pain before surgery, so why all of a sudden do I have it now. He keeps telling me its because of my age and that it’s because I’m dry, but that’s not the case, the pain is right up front and is extremely painful, even if I use a lot of lubricant. I think it’s more than just me getting old, I think something happened, I just don’t know what. I’ve been to several doctors and they all stated they don’t feel any mesh, so I just don’t know why it hurts so bad. Please, if anyone has any suggestions or answers, please let me know. I’m sure there are a lot of other women out there with the same problem. Thanks

Getting older is insulting….. yes you may have dyspareunia for a variety of reasons but specific pain that you did not have before the implant should be examined and not dismissed. Check with a knowledgeable doctor. Here are some.

I went through the same hoopla. I was even told the pain was too high for mesh. Doctor’s are being told that estrogen takes care of the pain. I have my own theories on this. I had horrible pain on left side after 1 1/2 years, none on right. Mesh on both sides. I think we have concentrated nerve beds in areas and the mesh only needs to be ithin 1 cm to set off pain. On my right it wasn’t close enough. Until years later. I think it’s moving in. So depth of mesh probably makes a difference too. The severity of the pain you’re describing is too much for age. No pain before mesh – pain after – it’s the mesh.

I have the same issue was given estrace over and over with no help doctor says the same that don’t feel anything. My husband left me because he believes the doctor he thinks I am faking so I don’t have to have sex with him. I live in Ohio and ideas

Probably a doctor and a lawyer would be my suggestions… a doctor to give you an assessment of your situation other than estrace. Are you represented? Docs may include Veronikis, Raz , Miklos… write me if you need other names.

You know I forgot to mention that not only do I have severe pain with intercourse but I also have severe pain when I pee. It’s usually just at the start for a minute, but it hurts really bad. I just don’t understand why this has to happen. I will be going back to Dr. Raz in Jan. so I hope he has some answers. Because of insurance reasons I could not go to him this year. He was aware of my pain, but he too blamed it on menopause. So I hope he has an open mind when I see him next year. I really need to have this pain stop.

Hello S William…when I started menopause..age 50..i had cessation of periods. I had a quiet pelvis…no pain. Even though I noticed some bulging from prolapse…my pelvis was quiet.—no pain. There is NO PAIN WITH MENOPAUSE.

I JUST READ ON PACER, THAT MY CASE WAS DISMISSED-SETTLED.I CALLED MY LAWYER OFFICE AND THEY SAID IT IS STILL ACTIVE, THAT ETHICON HAS AGAINED TO SETTLE FOR MDL 2327.MY NAME IS ON THE LIST FOR SETTLMENT, BUT IM LAWYER OFFICE SAYS, THAT ETHICON HAS NOT SETTLED ON AN AMOUNT. I ASK WHAT TIER I AM AND THE LAWYER OFFICE SAID THEY DIDN;T KNOW, THAT THE DEFENDENT WAS THE ONE THAT DECIDED THAT. I NEVER GET TO TALK TO THE ACTUAL LAWYER , ITS ALWAYS ONE OF THEIR AIDES. I DON’T UNDERSTAND THIS PROCEEDINGS, IF SOMEONE CAN EXPLAIN WHATS GOING ON AND HOW LONG THIS ILL TAKE.IT SEEMS ALOT OF US HAVE GONE THRU ALOT OF STUFF ITH ETHICON/J &J PRODUCTS THAT DID DAMAGE, SO I TINK WE SHOULD KNOW WHAT ALL HAPPENS STEP BY STEP, THANKS

My thought is they actually may be confused with the tier process. Recall…that one of Jane’s followers stated she had 8 surgeries and ended up with $2,000. Perhaps they may believe that some of us are self inflicting harm. Just saying

THAT REALLY TELLS YOU HOW IGNORANT THESE DRs’ are. .The name ESTRACE itself is repulsive. I lived on a farm and when the Cows were in Estrus (In heat) we got the bull out for her to conceive. It is so disgusting that they named this pill Estrace.